Methods and apparatus for securing and tensioning a urethral sling

ABSTRACT

Improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. The urethral sling is preferably formed of a flexible sheet material extending between opposed first and second sling ends and bounded by opposed first and second sling sides. The urethral sling is selectively tensioned in a central portion intermediate the first and second sling ends and/or in one or both of end portions bracketing the central portion. In one embodiment, pre-positioned plicating lines in the central portion are selectively drawn and tied to slacken the central portion and tension the end portions. In further embodiments, bone anchor lines passed through locations displaced from the sling ends are drawn and fixed to tension the central portion between the displaced locations and slacken the end portions.

RELATED APPLICATIONS

This application is a division of U.S. Ser. No. 11/381,668, filed May 4,2006, titled METHODS AND APPARATUS FOR SECURING AND TENSIONING AURETHRAL SLING TO PUBIC BONE, by Amal et al., which claims priority toU.S. Provisional Application Ser. No. 60/677,456 filed May 4, 2005, theentireties of both applications being incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains to surgical procedures, kits, andimplants to alleviate human incontinence, and particularly to improvedmethods and apparatus to secure a urethral sling to pubic bone in asub-urethral location and tensioning the urethral sling to support theurethra and alleviate incontinence.

BACKGROUND OF THE INVENTION

Incontinence is a condition characterized by involuntary loss of urine,beyond the individual's control, that results in the loss or diminutionof the ability to maintain the urethral sphincter closed as the bladderfills with urine. Male or female stress urinary incontinence (SUI)occurs when the patient is physically or emotionally stressed.

One cause for this condition is damage to the urethral sphincter or lossof support of the urethral sphincter, such as can occur in males afterprostatectomy or following radiation treatment, or that can occur due topelvic accidents and aging related deterioration of muscle andconnective tissue supporting the urethra. Other causes of maleincontinence include bladder instability, over-flowing incontinence andfistulas.

The female's natural support system for the urethra is a hammock-likesupportive layer composed of endopelvic fascia, the anterior vaginalwall, and the arcus tendineus (a distal attachment to the pubic bone).Weakening and elongation of the pubourethral ligaments and the arcustendineus fascia pelvis, weakening of the endopelvic fascia andpubourethral prolapse of the anterior vaginal wall, and their complexinteraction with intraabdominal forces are all suspected to play a rolein the loss of pelvic support for the urethra and subsequenthypermobility to an unnaturally low non-anatomic position, leading tourinary incontinence.

Females can also exhibit cystocele, a condition due to laxity of thepelvic floor wherein the bladder extrudes out and downwards causing SUI.The severity of this bladder collapse is rated between Grades onethrough four. In Grade four cystocele, the bladder extrudes out of thevaginal opening. The treatment of choice for this condition includes thereduction or closing of the pelvic floor opening from which the bladderdescends using sutures. As noted below, other procedures involvingimplantation of a urethral sling are also gaining acceptance.

In general, continence is considered to be a function of urethralsupport and coaptation. For coaptation to successfully prevent or cureincontinence, the urethra must be supported and stabilized in its normalanatomic position.

The present application is directed to the treatment of SUI and chronicurinary incontinence due to inability of the urethral sphincter to closeor remain closed as bladder fluid pressure builds. Currently,incontinence treatments of choice involve implantation of a KaufmanProsthesis, an artificial sphincter (such as the AMS-800 Urinary ControlSystem available from American Medical Systems, Inc.), or a urethralsling procedure in which a urethral sling is inserted beneath theurethra and advanced in the retro pubic space. Peripheral portions ofthe elongated urethral sling are affixed to bone or body tissue, and acentral portion of the elongated urethral sling extends under theurethral or bladder neck to provide a platform that compresses theurethral sphincter, limits urethral distention, and pelvic drop, andthereby improves coaptation.

Male and female urethral sling procedures are disclosed in commonlyassigned U.S. Pat. Nos. 6,406,480, 6,652,450 and 6,382,214, for example,and further female urethral sling procedures are described in commonlyassigned U.S. Pat. No. 6,641,524, for example, and publications andpatents cited therein. The implantation of certain urethral slingsinvolves the use of delivery systems configured for and techniques thatinvolve transvaginal, transobturator, supra-pubic and pre-pubicexposures or pathways.

The above-referenced '214 and 480 patents describe apparatus and methodsfor treatment of male incontinence and female cystocele repair in whicha urethral sling material is positioned between the descending pubicrami of the pubic bone. In such an operation a “hammock-like” urethralsling material is sutured below the urethra in males, or below theposterior bladder wall in the case of cystocele in females. The urethralsling material may comprise synthetic material or cadaveric orautologous fascia and may or may not be absorbable over time.

In the male case, the urethral sling applies passive compression againstthe bulbar urethra. The compression, either by itself or in conjunctionwith urethral mobility, prevents urine leak during strain. If additionalpassive pressure is required on the urethra after surgery is completed,collagen or other bulky material can be injected with a tiny needlethrough the perineum, causing more pressure created by the bulkymaterial on one side (the lower or caudal side) by the urethral sling,and on the other (the upper or superior) side compressing the urethra.An example of a urethral sling sutured to and extending between fourbone anchors or screws fixed to the descending pubic rami is depicted inFIG. 12 of the above-referenced '214 patent.

One minimally invasive surgical procedure that incorporates theteachings of the above-referenced '214 patent to alleviate mild tomoderate male SUI is performed employing the InVance™ Male UrethralSling System for implanting the InteMesh™ Synthetic Surgical Mesh (bothavailable from American Medical Systems, Inc.) in a manner generallydescribed in the above-referenced '214 patent. The InteMesh™ SyntheticSurgical Mesh is about 4 cm×7 cm and knitted from a supple polyestermaterial coated with silicone, the knitted mesh having a pore size thatallows for tissue ingrowth during chronic implantation. The InVance™Male Urethral sling System includes four to six, typically, titaniumbone anchors or screws and a disposable, battery powered, inserter ordriver. Each bone screw has a distal self-tapping spiral thread and alength of No. 1 Prolene suture extending proximally from the bone screw.

In the implantation procedure, the patient is first placed in thelithotomy position and draped, and the surgical field is prepared. A 16French Foley catheter, for example, is inserted into the urethra, thecatheter balloon is inflated t to assist the surgeon in identifying theurethra during dissection, and the scrotum is elevated. A verticalincision is made over the midline in the perineum, and the skin andsubcutaneous tissues are dissected free. The bulbocavernous muscle isthen exposed, and dissection is carried out posteriorly to the area ofthe transverse perineum to completely free the bulbar urethra. Lateraldissection is used to expose the corpora cavernosum and the descendingpubic rami.

The six titanium bone screws are then screwed, one at a time, into theinner portion of the descending pubic rami of the pubic bone using thebattery-powered driver. The bone screws are screwed fully into the pubicbone so that the No. 1 Prolene sutures extend outward from each bone.The location of each bone screw and the order of bone screw insertioncan be selected by the surgeon. In one approach, the first pair of bonescrews is inserted just below the symphysis, the second pair is insertedjust proximal to the level of the ischial tuberosity, and the third pairis inserted intermediate the first and second pair.

The InteMesh™ Synthetic Surgical Mesh is then applied against the arrayof bone screws bridging the lower surface of the bulbar urethra betweenthe descending pubic rami to determine where the sutures will be passedthrough the mesh pores and tied off. The sutures extending from one ofthe descending pubic rami may be first passed though selected mesh poresand tied off employing several surgeon's suture knots. Tension is thenapplied to the other side or end of the urethral sling as it is drawnagainst the other pubic pubic ramus to determine where the bone screwsutures should be passed through the mesh pores and tied off.

The determination of the appropriate tension may be accomplished using acough test or Retrograde Perfusion Pressure (RPP) test. To perform a RPPtest, the Foley catheter balloon is then deflated, and the Foleycatheter is withdrawn and connected to a sterile saline perfusion line.A zero pressure state is obtained by lowering the bag to the level ofthe symphysis. The tip of the catheter is repositioned at thepenoscrotal angle, and the urethral resistance to start of flow orleakage is recorded (by distance of the bag above the level of thesymphysis). In patients under anesthesia suffering from sphincterincontinence, the urethral resistance is very low. Tension is thenapplied to the untied side of the urethral sling by advancing the end ofthe urethral sling along the sutures toward the bone screws so that theurethral sling bears against the bulbar urethra. The mesh urethral slingcompresses the bulbar urethra as it is adjusted in tension to increaseurethral resistance to withstand a pressure selected between 30 and 60cm of water. The sutures are then tied to maintain the selected tension.

The Foley catheter is then advanced to the bladder (which should advancewithout difficulties), and the wound is irrigated with Bethadinesolution and closed in layers. Subsequently, the Foley catheter isremoved after 2 hours, and the patient can be discharged home on oralantibiotics and pain medication after completing a successful voidingtrial.

The above-referenced '214, '480, and '524 patents also discloseprocedures for repairing a cystocele using retropubic and lateral pubicbone anchors. The surgery disclosed in the '214 patent is indicated forpatients with grade four cystocele and urethral hypermobility. Theprocedure repairs the central defect, the lateral detect, approximatesthe cardinal ligaments to the midline, and creates a urethral sling ofthe urethra.

After preparation and draping, a Foley catheter is inserted in thebladder. Once the catheter is in place, a “goal post” incision is made.The vertical bars of the goal post extend laterally from the distalurethra to the horizontal bar that is made just proximal to the bladderneck. The vertical bars reach the vaginal cuff.

After creation of the goal post incision, the vaginal wall is dissectedfree to expose the perivesical fascia laterally and the cardinalligaments posteriorly. A figure eight 2-0 absorbable suture is appliedto approximate the cardinal ligament to the midline without tying it. Ifan enterocele sac is encountered, it should be repaired at this stage.

The retropubic space is then entered over the periurethral fascia at thelevel of the vertical bars of the incision, and the urethropelvicligaments are exposed. Two fascial anchors (the upper pair) are insertedinto the tissue of the suprapubic area. These anchors may comprise abone screw having a distal self-tapping screw thread of the typedescribed above with a No. 1 Prolene suture attached to the proximal endof the bone screw. Other types of bone anchors are disclosed in theabove-referenced '480 patent.

In an alternative embodiment, at this stage of the procedure, theretropubic space is not open and two bone anchors or screws of the typedescribed above are applied to the inner surfaces of the symphisis usinga right angle drill.

After application of the first set of anchors, a second pair of boneanchors or screws of the types described above and in theabove-referenced '480 patent are applied to the inner surface of thedescending pubic rami of the symphysis.

Once the four bone screws are in place, the bladder prolapse is reducedusing a moist sponge over a right angle retractor. Alternatively, aDexon mesh is applied and left in place. The lower pair of Prolenesutures are then used to incorporate the perivesical fascia and thecardinal ligaments area. Interrupted 2-0 absorbable sutures are used toapproximate the perivesical fascia to the midline over the Dexon mesh.

A variation on this procedure is set forth in commonly assigned, U.S.Patent Application Publication No 2002/0183762 to provide urethralsupport and coaptation employing the InFast™ Ultra Transvaginal Urethralsling System for implanting a urethral sling selected from among theInteXen™ Porcine Dermal Matrix or the InteDerm™ Allograft Dermal Matrixor the InteLata™ Allograft Fascia Lata (all available from AmericanMedical Systems, Inc.). The selected urethral sling is intended to becut to size and in a T-shape to fit between the bone screws and to beattached thereto as described above. The InFast™ Ultra Female Urethralsling System includes four, typically, titanium bone screws and adisposable, battery powered, inserter that positively engages the bonescrew to drive it into bone. In this system, a length of No. 1 Prolenesuture is passed through a metal ring extending proximally from the bonescrew, and the ends of the suture are joined to needles adapted to bepassed through the urethral sling. A distal end of a drive shaft of thebattery-powered inserter engages the bone screws, and the drive shaft isshaped to enable orientation of the screw threads toward the posterioraspect of the pubic bone.

The tensioning of the selected urethral sling is accomplished in thisprocedure as the suture needles are passed through the urethral sling,and the urethral sling is pressed against the bone surface. The sutureneedles are severed, and the suture ends are tied together. The tiedsuture knot is slid upward and posteriorly (behind the bone) to ensurejuxtaposition of the sling end to the bone surface.

The above-described bone screws are intended to be driven into the boneuntil completely embedded with the suture extending out of theself-tapped bore in the bone.

Thus, in the above-described procedures, the urethral sling inmaintained in place, and sling tension is adjusted and applied throughthe tied sutures. The procedure of initially tensioning and tying thesutures takes an undue amount of the surgical time, up to 15-25 minutesas observed in some instances employing the InVance™ Male Urethral SlingSystem for implanting the InteMesh™ Synthetic Surgical Mesh. Moreover,it is sometimes difficult to achieve the tension in the urethral slingthat is sufficient to constrict the urethral sphincter to provideurethral resistance to leakage at the selected water bag height, e.g. at60 cm.

It would be desirable to simplify the process of and to reduce theamount of time that it takes to tension and secure the urethral mesh tothe sutures extending from bone anchors of the types described above.

If the resulting sling tension is not adequate, it may be necessary tountie the tied sutures to readjust tension including possiblyrepositioning the bone anchor in the pubic bone or the sutures extendingthrough the urethral sling. Tying, untying and retying the suture knotsconsumes further time. Thus, it would be desirable to simplify theprocess of and to reduce the amount of time that it takes to detach,adjust tension, and reattach the urethral mesh to the sutures extendingfrom bone anchors.

Moreover, the sutures may have been trimmed at the knot following anearlier tying. Applying tension through and retying the trimmed suturesmay be difficult to accomplish. Therefore, it would be desirable tosimplify the process of tensioning the sutures in a manner that does notrequire untying and retying the sutures and is not compromised bytrimming the suture length.

SUMMARY OF THE INVENTION

The preferred embodiments of the present invention incorporate a numberof inventive features that address the above-described problems that maybe combined as illustrated by the preferred embodiments oradvantageously separately employed. It will be understood that theinventive features and preferred embodiments may be applied in treatingboth male and female patients.

In one aspect of the present invention, a urethral sling is preferablyformed of a flexible sheet material extending between opposed first andsecond sling ends and bounded by opposed first and second sling sides.The urethral sling is provided with at least one pre-positioned,plicating line, e.g., a suture, having a plicating line length extendingbetween first and second plicating line free ends. An intermediateportion of the plicating line is passed through the material of theurethral sling between at least first and second points disposedintermediate first and second sling ends. The intermediate portion ofthe pre-positioned, plicating line thus extends generally across acentral portion of the urethral sling displaced from the first andsecond sling ends.

In use, the urethral sling is affixed by any of the known techniques tothe bone screws or anchors inserted into the pubic bones to extendlaterally across and support the urethra, and testing for urethralresistance to leakage may be conducted. The plicating line free ends ofthe one or more pre-positioned plicating line may be gripped and drawntogether to draw a fold or crease in the sling material (i.e., toplicate the sling material) in the central portion of the urethralsling, whereby the urethral sling material is drawn tight in first andsecond end portions bracketing the central portion. Thus, the urethralsling is tensioned by the tension of the plicating line against theurethra to increase urethral resistance to leakage. The resistance toleakage may be rechecked, and the plicating line free ends tied togetherto maintain the slack or fold or crease and resulting sling tension thatprovide an acceptable urethral resistance to leakage.

In preferred embodiments, the length of plicating line may be passedthrough the material of the urethral sling at further pointsintermediate the first and second points. In addition, the plicatingline free ends may be folded against one side of the urethral sling andheld there to avoid entanglement during or interference with theprocedure. The plicating line free ends are held in place by threadingthrough additional suture pores until released for use.

In further preferred embodiments, more than one plicating line isprovided extending across the central portion of the urethral sling sothat the urethral sling may be tensioned more precisely between thefirst and second sling sides. Unused plicating lines may be left inplace or retracted from the urethral sling.

In a further aspect of the present invention usable separately ortogether with the above-described aspect of the invention, anchorfixation lines extending from each bone anchor are employed alone or inconjunction with line retainers to affix an implantable medical devicein the patient's body. Each bone anchor comprises a bone anchor bodyhaving a bone fixation end and an elongated bone anchor line affixed atone line end to the bone anchor body and extending to an anchor linefree end.

In one variation, the anchor line comprises at least one line fixationelement shaped to be fitted with the device fixation element to affixthe medical device to the bone anchor. In other variations, the anchorlines comprise a plurality of line fixation elements spaces along theanchor line length to be selectively fitted to the device fixationelement.

In the context of implanting a urethral sling formed of a mesh fabric,the device fixation element comprises a selected mesh pore. In thisaspect of the invention, each bone anchor line is inserted through thesling material at a location of the urethral sling displaced from asling end and the site where the bone anchor is affixed into the pubicbone. Generally speaking, the bone anchor line or line pair extends fromeach bone anchor affixed to one pubic bone toward a bone anchor affixedto the other pubic bone and is passed through the sling material at thedisplaced location. In preferred embodiments, the bone anchor lines arein this way extended across first and second end portions of theurethral sling and passed through the sling material at the displacedlocations, whereby the central portion of the urethral sling is boundedby the displaced locations. The bone anchor lines are selectivelytensioned and fixed at the displaced locations to slacken and possiblyinduce a fold or crease or plication in the first and/or second endportions and tension the central portion.

In one preferred embodiment, a line retainer is provided that can beselectively advanced over the bone anchor line extending through themesh and against the urethral sling to maintain the tension. Inpreferred embodiments, the line retainer is resilient and has a retainerbore sized and shaped to be expanded to pass over the bone anchor line(including any outwardly extending line fixation elements) as theretainer is advanced toward the bone anchor and that resists retractionover the bone anchor away from the bone anchor. Retainer-dispensingtools may be provided that facilitate application of the retainers overthe anchor lines.

After adequate tension is achieved with or without use of lineretainers, the anchor lines may be tied off with fewer or smaller knotsto reduce suturing time, and the final exposed line trimmed.

It will be understood that the present invention may be practicedemploying any suitable bone anchor line and bone anchors of any of thetypes known in the prior art, including those disclosed in theabove-referenced '480 patent.

Advantageously, the procedure for attaching the urethral sling to boneanchors is simplified to shorten the surgical time, the tensioning andfixation are made more reliable, and any line knots that are employedare reduced in size.

This summary of the invention has been presented here simply to pointout some of the ways that the invention overcomes difficulties presentedin the prior art and to distinguish the invention from the prior art andis not intended to operate in any manner as a limitation on theinterpretation of claims that are presented initially in the patentapplication and that are ultimately granted.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other advantages and features of the present invention will bemore readily understood from the following detailed description of thepreferred embodiments thereof, when considered in conjunction with thedrawings, in which like reference numerals indicate identical structuresthroughout the several views, and wherein:

FIG. 1 is a schematic illustration of the fixation of bone anchors orscrews to descending pubic rami with lines extending from the bonescrews;

FIG. 2 is a schematic illustration of the fixation of a urethral slingto the bone screws with the lines extending from the bone screws inaccordance with the prior art resulting in insufficient tensioning incertain instances;

FIG. 3 is a plan view of an embodiment of a urethral sling in accordancewith the present invention with one or more pre-positioned plicatingline extending across the urethral sling;

FIG. 4 is a side view of the urethral sling of FIG. 3;

FIG. 5 is an expanded side view of a bone anchor, particularly a bonescrew of the type employed in FIGS. 1 and 2, with a pair of bone screwlines extending from the screw body;

FIG. 6 is a schematic illustration of the urethral sling fixed to thebone screws with the plicating line(s) of the urethral sling of FIG. 3drawn and tied to form a fold or crease in the urethral sling to adjusttension and obtain satisfactory urethral resistance;

FIG. 7 is a plan view of an embodiment of a line button adapted to beapplied over the lines extending from the bone screw of FIG. 5;

FIG. 8 is a plan view of a further embodiment of a line button adaptedto be applied over the lines extending from the bone screw of FIG. 5;

FIG. 9 is a side view in partial cross-section illustrating the passageof bone screw lines of a bone screw affixed to a descending pubic ramusthrough a mesh pore of the urethral sling and tensioning the urethralsling by drawing a line button of FIG. 7 or 8 over the lines and againstthe urethral sling;

FIG. 10 is a schematic illustration of the urethral sling fixed to thebone screws with the bone screw lines drawn through the line buttons toform folds or creases in the urethral sling to adjust tension and obtainsatisfactory urethral resistance;

FIG. 11 is an expanded side view of a bone anchor, particularly a bonescrew, with a bone screw line extending from the screw body shaped withperiodic spherical fixation elements;

FIG. 12 is a side view illustrating the passage of the bone screw lineof the bone screw of FIG. 11 affixed to a descending pubic ramus througha mesh pore of the urethral sling and tensioning the urethral sling byprogressively drawing spherical fixation elements through a mesh pore tobear against the urethral sling;

FIG. 13 is an expanded side view of a bone anchor, particularly a bonescrew, with a bone screw line extending from the screw body shaped withperiodic barbed fixation elements; and

FIG. 14 is a side view illustrating the passage of the bone screw lineof the bone screw of FIG. 13 affixed to a descending pubic ramus througha mesh pore of the urethral sling and tensioning the urethral sling byprogressively drawing barbed fixation elements through a mesh pore tobear against the urethral sling.

It will be understood that the drawing figures are not necessarily toscale.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In the following detailed description, references are made toillustrative embodiments of methods and apparatus for carrying out theinvention. It is understood that other embodiments can be utilizedwithout departing from the scope of the invention. Preferred methods andapparatus are described for tensioning urethral slings fixed to pubicbones. It will be understood that the term “urethral sling” encompassesany type of sling, tape, hammock or the like that supports andor/applies compression to the urethra. The urethral sling may be formedof any biocompatible flexible sheet material known in the art with orwithout pores or openings through the sheet material.

For convenience of illustration of the aspects of the present invention,the preferred embodiments simply depict the bone anchors as bone screws.It will be understood that the present invention may be practicedemploying bone anchors of any of the types known in the prior art, e.g.,those disclosed in the above-referenced '480 patent.

For convenience of illustration of the aspects of the present invention,the preferred embodiments are described in the context of implantationof a urethral sling in a male patient. It will be understood that thepresent invention is not so limited and may also be practiced in theimplantation of urethral slings in female patients.

It will be understood that the fixation lines and plicating linesdisclosed herein may be but are not necessarily formed of lengths ofsuture.

Referring to FIGS. 1 and 2, the male anatomy in the pelvic region 10 isdepicted schematically to illustrate how a urethral sling 30 is affixedto the right and left descending pubic rami 24 and 26 to extend acrossand support the male urethra 12 in the manner described above, forexample, in the procedure employing the InVance™ Male Urethral SlingSystem for implanting the InteMesh™ Synthetic Surgical Mesh urethralsling.

An embodiment of an improved urethral sling 30 of the present invention,which can be implemented in the InteMesh™ Synthetic Surgical Meshurethral sling, is depicted in greater detail in FIGS. 3 and 4. In apreferred embodiment, the urethral sling 30 is knitted from a supplepolyester yarn to have a plurality of sling or mesh pores 40 and iscoated with medical grade silicone rubber. The knitted mesh pores 40have a pore size that allows for tissue ingrowth therethrough duringchronic implantation. The urethral sling 30 extends end-to-end betweenfirst and second sling ends 32 and 34 and side-to-side between first andsecond sling sides 36 and 38. At least one plicating line 50 having aline length extending between first and second line free ends 52 and 54is fitted through mesh pores 40. An intermediate line portion 56 ispassed through two or more mesh pores 40 to extend the line lengthbetween points 58 and 60 across the urethral sling 30 intermediate thefirst and second sling ends 32 and 34 and either parallel to or at anangle to the first and second sling sides 36 and 38.

In preferred embodiments, the intermediate portion 56 of plicating line50 may be passed through further pores 40 of the urethral sling 30 atpoints intermediate the first and second points 58 and 60. The line freeends 52 and 54 may be folded against one side of the urethral sling 34and held there by passing them through additional pores as shown in FIG.4. The line free ends 52 and 54 are released from the

Additional plicating lines 50′ and 50″, for example, are depicted inFIG. 3 passing through the mesh pores 40 in the manner described aboveproviding an exemplary illustration of a further preferred embodiment ofa urethral sling 30.

Returning to FIGS. 1 and 2, as noted above, the surgical field isprepared after the patient, placed in the dorsal lithotomy position anddraped. The scrotum 14 and penis 16 are elevated, a vertical incision ismade over the midline in the perineum of the skin and subcutaneoustissues (not shown) are dissected to the side to expose thebulbocavernous muscle 20. Lateral dissection is used to expose thecorpora cavernosum 22 and the surfaces of the descending pubic rami 24and 26.

As shown in FIG. 1, the illustrated fixation of the surgical urethralsling 30 is effected employing six titanium bone screws 64, 66, 68, 70,72, 74 sequentially driven by a disposable, battery powered, inserter ordriver (not shown). Each bone screw 64, 66, 68, 70, 72, 74 has an anchoror screw body with a distal, self-tapping, spiral thread adapted to bescrewed into bone when the screw tip is applied to the bone surface andthe driver is powered. A pair of No. 1 Prolene suture lines 84, 86, 88,90, 92, 94 extend proximally from each bone screw 64, 66, 68, 70, 72,74, respectively. One such bone screw 64 with the pair of bone screwlines 84 extending from the screw body is depicted in the expanded viewof FIG. 5. Typically, the pair of bone screw lines is crimped at one endinto a bore of the bone screw and extends about 30 cm to bone screw linefree ends. The bone screw line free ends can be joined as by use ofultrasonic welding to ease in handling and use of a bone screw fixationtool. The surgeon may choose to pass the joined line free ends through aselected mesh pore, tie a knot or knots, and then trim the lines. Or,the surgeon may first trim the lines, separately pass the severed linefree ends through a common or separate mesh pores, tie a knot or seriesof knots, and again trim the line free ends.

The bone screws 64, 66, 68, 70, 72, 74 are screwed fully into the boneof the so that the No. 1 Prolene lines 84, 86, 88, 90, 92, 94,respectively, extend outward of the descending pubic rami 24 and 26 asshown in FIG. 1. The surgeon can select the location of each bone screw64, 66, 68, 70, 72, 74 and the order of insertion. In one approachdepicted in FIG. 1, a first pair of bone screws 64, 70 is inserted justbelow the symphysis, the second pair 66, 72 is inserted proximal to thelevel of the ischial tuberosity, and the third pair 68, 76 is insertedintermediate the first and second pair.

The urethral sling 30 is then applied against the array of bone screws64, 66, 68, 70, 72, 74 bridging the lower surface of the bulbar urethra20 between the descending pubic rami 24 and 26 to determine where eachline of the respective line pairs 84, 86, 88, 90, 92, 94 will be passedthrough mesh pores.

The free ends of each line of each line pair 84, 86, 88, 90, 92, 94 aresequentially grasped, passed through separate mesh pores and drawn tightand tied together against the mesh of the urethral sling 30.

The lines of the line pairs 84, 86, 88 extending from the descendingpubic ramus 24 may be first passed though selected mesh pores adjacentthe first sling end 32. The first sling free end 32 is then pressedagainst the descending pubic ramus 24. The free ends of each line ofeach line pair 84, 86, 88 are sequentially grasped, drawn tight and tiedtogether at least two times forming several surgeon's line knots againstthe mesh of the urethral sling 30 firmly holding the sling first endagainst the descending pubic ramus 24.

Tension is then applied to the second sling end 34 of the urethral sling30 as it is drawn against the second pubic ramus 26 to determine wherethe lines of the bone screw line pairs 90, 92, 94 should be passedthrough mesh pores and tied off in the manner described above. Testingfor urethral resistance to leakage may be conducted employing thetechniques and instruments described above as the lines of bone linepairs 90, 92, 94 are drawn tight against the fabric of urethral sling 30and tied off. The lines of bone line pairs 90, 92, 94 may be retractedfrom the initially selected pores 40 and reinserted in other pores 40 inthe process of optimizing the tension. In this way, the urethral sling30 is eventually lined to all of the bone anchors or screws 64, 66, 68,70, 72, 74 inserted into the descending pubic rami 24 and 26 to extendlaterally across and support the bulbar urethra 20. An intermediateportion of the urethral sling 30 extends between the bone screws 64, 66,68 and the bone screws 70, 72, and 74.

The testing for urethral resistance may reveal that tension applied bythe intermediate portion of the urethral sling 30 to the urethra 12 isinsufficient to halt leakage despite the attempts to optimize urethralresistance. This deficiency and the preceding urethral resistanceoptimization tests and efforts may be advantageously minimized by takingthe further steps of freeing the line free ends 52 and 54 of theplicating. line(s) 50, 50′, 50″ from the retained position shown insolid lines in FIG. 4 toward one another as shown in broken lines inFIG. 4 and tying them together with one or more surgeon's knot.

More particularly, the plicating line free ends 52 and 54 may be grippedand drawn together after being freed from retention to shorten thedistance between the first and second points, thereby shortening adimension of the urethral sling 30 and tensioning it against the urethra12 to increase urethral resistance to leakage. The resistance to leakagemay be rechecked, and the plicating line free ends 52 and 54 tiedtogether to maintain the shortened dimension and tension that providesan acceptable urethral resistance to leakage. The knotted plicating linefree ends 52, 54 of each of the plicating lines 50, 50′, 50″ are shownoverlying the mesh of the urethral sling 30 in FIG. 4. As also shown inFIG. 6, a mesh fold is created in the central portion as the urethralsling 30 is tensioned by the tied together, plicating line free ends 52,54.

In this way, the pre-positioned plicating lines 50, 50′ 50″ slacken ordraw a fold or crease in the sling material in the central portion ofthe urethral sling 30, whereby the urethral sling material is drawntight in first and second end portions bracketing the central portion.Thus, the urethral sling 30 is tensioned by the tension of the plicatinglines 50, 50′, 50″ against the urethra to increase urethral resistanceto leakage. The resistance to leakage may be rechecked, and theplicating line free ends tied together to maintain the slack or fold orcrease and resulting sling tension that provide an acceptable urethralresistance to leakage.

Unused plicating lines among lines 50, 50′, 50″ may be left in place orwithdrawn from the mesh pores 40 of the urethral sling 30 and disposedof.

The tensioning of a urethral sling, e.g., the InteMesh™ SyntheticSurgical Mesh urethral sling or the above-described urethral sling 30can be enhanced in a further way. For convenience, the urethral sling 30will be employed in describing the following embodiments, but itunderstood that the plicating lines 50, 50′, 50″ may be absent or may beemployed in the manner described above to augment tensioning of theurethral sling 30.

In these embodiments, each bone screw (or other bone anchor) line isinserted through a selected mesh pore 40 in a portion or at a locationof the urethral sling 30 displaced from the site where the bone screw isscrewed into the descending pubic ramus and intermediate the sling firstand second ends 32 and 34. The urethral sling 30 is urged toward eachbone screw screwed into the descending pubic ramus to slacken or form afold or crease in the end portion of the urethral sling 30 between thebone screw and the selected mesh pore 40 that tensions the centralportion of the urethral sling 30. In the following description of thisaspect of the invention, it will be understood that either or both ofthe end portions of the urethral sling 30 can be made slack or have afold or crease induced therein.

Thus, in the embodiment of this aspect of the invention illustrated inFIGS. 7-10, the bone screws 64, 66, 68 are screwed into the descendingpubic ramus 24 and the bone screws, 70, 72, 74 are screwed into thedescending pubic ramus 26 in the manner depicted in FIG. 1 and describedabove. The bone line pairs 84, 86, 88, 90, 92, 94 (or a single line)extend from the respective bone screw 64, 66, 68, 70, 72, 74 as alsoshown in FIG. 1.

In accordance with this embodiment, a line retainer, e.g., one of theline button 100 depicted in FIG. 7 or the line button 110 depicted inFIG. 8, is provided for fixation of each bone line pair 84, 86, 88, 90,92, 94 extending through a selected mesh pore 40. The line buttons 100and 110 have a thickness and lateral dimension, e.g., the major andminor diameters of the ellipse shaped line button 100 and the diameterof the circular line button 110 that are suitable for implantation atthe site and cannot be passed through a mesh pore 40 at the elasticlimits of the yarn forming the urethral sling 30. It will be understoodthat the line retainers may have any shape and size suitable for thepurposes of applying retaining force against a portion of the urethralsling 30 and resisting passage through a mesh pore 40.

The line buttons 100 and 110 are formed with centrally located buttonapertures 102 and 112, respectively, that are sized and shaped toreceive and frictionally engage a bone screw line pair (or single line)as shown in FIGS. 9 and 10. The button aperture 102, 112 is shaped toallow a bone screw line to be inserted through it so that the linebutton 100, 110 may be advanced over the line pair toward the portion ofthe urethral sling 30 surrounding a selected mesh pore 40 that the linepair extends through as shown in FIG. 9 to apply force thereto. Thebutton aperture 102, 112 is also shaped to maintain the applied force byresisting retraction of the line button 100, 110 along the line pair inthe direction away from the bone screw 64 depicted in FIG. 9. Exemplarybutton aperture shapes are depicted in FIGS. 7 and 8 that form a pair ofresilient flaps separated by a aperture that is smaller than thediameters of the bone screw lines (or line). The passage of the linepair 84 (or single line) widens the aperture and displaces the flapsaway from the bone screw 64 as shown in FIG. 9 to resist slippage.

The line buttons 100 and 110 are preferably formed of a biocompatiblematerial suitable for chronic implantation and having a resilienceenabling the widening of the aperture between the flaps as depicted inFIG. 9 but resisting slippage. It will be understood that the buttonapertures 102 and 112 may take any other shape and size that allowsadvancement in one direction and resists retraction in the oppositedirection.

In use, the lines of the line pairs 84, 86, 88 extending from thedescending pubic ramus 24 may be each first passed though a selectedadjacent mesh pore 40 adjacent the first sling end 32. The first slingfree end 32 is then pressed against the descending pubic ramus 24. Thefree ends of each line of each line pairs 84, 86, 88 are sequentiallygrasped, drawn laterally toward the descending pubic ramus 26 andextended through a more remote mesh pore 40, whereby an edge portion ofthe urethral sling is disposed between the adjacent and remote meshpores 40. In each case, a line button 100 or 110 is then applied overeach of the line pairs 84, 86, 88 and advanced sufficiently toward therespective bone screws 64, 66, 68 to stay in place.

The procedure is then repeated to route the bone line pairs 90, 92 and94 through adjacent and remote mesh pores 40 and to loosely apply a linebutton 100 or 110 over each of the line pairs 90, 92, 94 and advancedsufficiently toward the respective bone screws 70, 72, 74 to stay inplace. The line buttons 100 or 110 over each of the bone line pairs 84,86, 88, 90, 92, 94 are then selectively and sequentially advanced towardthe respective bone screws 64, 66, 68, 70, 72, 74 to tension theurethral sling 30 intermediate the three line buttons 100 or 110proximate the descending pubic ramus 24 and the three line buttons 100or 110 proximate the descending pubic ramus 26. Testing for urethralresistance to leakage may be undertaken as described above to judge thesufficiency of the tensioning.

The application of the line buttons 100 or 110 and the tensioning of theurethral sling 30 are schematically depicted in FIG. 10. Forconvenience, the selected line buttons 100 or 110 applied over the bonescrew lines 84, 86, 88, 90, 92, 94 are numbered respectively as 144,146, 148, 150, 152, 154. The tensioning process may induce creases orfolds 132 and 134 in the end portions of the urethral sling 30 adjacentthe respective sling ends 32 and 34 and on either side of the tensionedintermediate portion of the urethral sling 30 as shown in FIG. 10. Itwill be understood that the free ends of the line pairs 84, 86, 88, 90,92, 94 (or single lines) can be tied together or otherwise knotted withsurgical knots over the line buttons 144, 146, 148, 150, 152, 154 if itis considered desirable to do so.

A still further embodiment of the invention for applying tension to theurethral sling 30 in the manner depicted in FIG. 10 is illustrated inFIGS. 11 and 12. FIG. 11 illustrates a bone anchor, particularly a bonescrew 64, with a bone screw line 114 extending from the screw body. Thebone screw line 114 is shaped like a key chain having periodic,enlarged, substantially spherical line fixation elements 118 separatedby reduced diameter link portions 116. The line fixation elements 118may be attached to or formed integrally with the bone screw line 114. Itwill be understood that in this embodiment, the bone screw lines 84, 86,88, 90, 92, 94 of each of the bone screws 64, 66, 68, 70, 72, 74 areshaped as exemplary bone screw line 114.

FIG. 12 illustrates the exemplary bone screw 64 of FIG. 11 affixed to adescending pubic ramus 24, 26, and the passage of the bone screw line114 through a remote mesh pore 40 of the urethral sling 30. The urethralsling 30 is tensioned by progressively drawing spherical fixationelements 118 through the remote mesh pore 40 to advance the remote meshpore 40 and surrounding portion of the urethral sling 30 toward the bonescrew 64. Thus, the process described above with respect to theembodiment of FIGS. 7-10 is followed to tension the intermediate portionof the urethral sling and to induce the folds or creases 132 and 134depicted in FIG. 10.

The tensioning of the intermediate portion of the urethral sling 30should elongate the remote pores 40 that bear against the sphericalfixation elements 118 so that the possibility of slippage by retractionof the spherical fixation elements 118 through the remote pores 40 isminimized. It will also be understood that a line button 100, 110 havinga suitably sized and shaped button aperture 102, 112 may be supplied tofit over the spherical fixation elements 118 and rest in a reduceddiameter link portion 116 to bear against the portion of the urethralsling surrounding the remote mesh pore 40 to reinforce the fixation andtensioning of the urethral sling 30.

Yet another embodiment of the invention for applying tension to theurethral sling 30 in the manner depicted in FIG. 10 is illustrated inFIGS. 13 and 14. FIG. 13 illustrates a bone anchor, particularly a bonescrew 64, with a bone screw line 124 extending from the screw body. Thebone screw line 124 is shaped to have periodic, enlarged, barbs 128separated by reduced diameter link portions 126. The barb-shaped linefixation elements 128 may be attached to or formed integrally with thebone screw line 124. It will be understood that in this embodiment, thebone screw lines 84, 86, 88, 90, 92, 94 of each of the bone screws 64,66, 68, 70, 72, 74 are shaped as exemplary bone screw line 124.

FIG. 14 illustrates the exemplary bone screw 64 of FIG. 13 affixed to adescending pubic ramus 24, 26, and the passage of the bone screw line124 through a remote mesh pore 40 of the urethral sling 30. The urethralsling 30 is tensioned by progressively drawing barbs 128 through theremote mesh pore 40 to advance the remote mesh pore 40 and surroundingportion of the urethral sling 30 toward the bone screw 64. Thus, theprocess described above with respect to the embodiment of FIGS. 7-10 isfollowed to tension the intermediate portion of the urethral sling andto induce the folds or creases 132 and 134 depicted in FIG. 10.

The barbs 128 are relatively resilient and may spread to resist slippageof the tensioned urethral sling 30. It will also be understood that aline button 100, 110 having a suitably sized and shaped button aperture102, 112 may be supplied to fit over the barbs 128 and rest in a reduceddiameter link portion 126 to bear against the portion of the urethralsling 30 surrounding the remote mesh pore 40 to reinforce the fixationand tensioning of the urethral sling 30

FIG. 14 is a side view illustrating the passage of the bone screw lineof the bone screw of FIG. 13 affixed to a descending pubic ramus througha mesh pore of the urethral sling and tensioning the urethral sling byprogressively drawing barbed fixation elements through a mesh pore tobear against the urethral sling.

Various combinations of the above-described aspects of the invention maybe made. For example, a line retainer, e.g., a line button 100, 110 ofFIGS. 7 and 8 could be passed over the plicating line free ends 52 and54 in lieu of the knots depicted in FIG. 6 to maintain the tensioninduced in the central portion of the urethral sling 30.

All patents and publications referenced herein are hereby incorporatedby reference in their entireties.

It will be understood that certain of the above-described structures,functions and operations of the above-described preferred embodimentsare not necessary to practice the present invention and are included inthe description simply for completeness of an exemplary embodiment orembodiments. It will also be understood that there may be otherstructures, functions and operations ancillary to the typical surgicalprocedures that are not disclosed and are not necessary to the practiceof the present invention.

In addition, it will be understood that specifically describedstructures, functions and operations set forth in the above-referencedpatents can be practiced in conjunction with the present invention, butthey are not essential to its practice.

It is therefore to be understood, that within the scope of the appendedclaims, the invention may be practiced otherwise than as specificallydescribed without actually departing from the spirit and scope of thepresent invention.

The invention claimed is:
 1. A method of implanting a urethral sling tosupport the urethra comprising: providing a urethral sling comprising: aflexible sheet material extending between opposed first and second slingends and bounded by opposed first and second sling sides; and aplurality of pre-positioned, plicating line having a plicating linelength extending between first and second plicating line free ends andpassed through the flexible sheet material at first and second pointsdisplaced from the respective first and second sling free ends such thatan intermediate portion of each plicating line extends across a centralportion of the urethral sling intermediate first and second end portionsof the urethral sling, the plicating lines being in substantiallyside-by-side relation between the first and second sling sides;surgically affixing the first and second sling ends to extend across theurethra; drawing one or more of the plicating line free ends together toinduce tension in the first and second end portions and apply tensionacross the central portion of the urethral sling; and tying theplicating line free ends; wherein: the providing step comprises affixingthe free ends of each plicating line through the sheet material attemporary retention points to hold the free ends against the flexiblesheet material; and the drawing step comprises releasing the free endsof each plicating line from the sheet material at the temporaryretention points.
 2. A method of implanting a urethral sling to supportthe urethra comprising: providing a urethral sling comprising: aflexible sheet material extending between opposed first and second slingends and bounded by opposed first and second sling sides; and at leastone pre-positioned, plicating line having a plicating line lengthextending between first and second plicating line free ends and passedthrough the flexible sheet material at first and second points displacedfrom the respective first and second sling free ends such that anintermediate portion of the plicating line extends across a centralportion of the urethral sling intermediate first and second end portionsof the urethral sling; surgically affixing the first and second slingends to extend across the urethra; drawing the plicating line free endstogether to induce tension in the first and second end portions andapply tension across the central portion of the urethral sling; andtying the plicating line free ends; wherein: the providing stepcomprises affixing the free ends of each plicating line through thesheet material at temporary retention points to hold the free endsagainst the flexible sheet material; and the drawing step comprisesreleasing the free ends of each plicating line from the sheet materialat the temporary retention points.
 3. A method of implanting a urethralsling to support the urethra comprising: providing a urethral slingcomprising: a flexible sheet material extending between opposed firstand second sling ends and bounded by opposed first and second slingsides; and at least one pre-positioned plicating line having a plicatingline length extending between first and second plicating line free endsand passed through the flexible sheet material at first and secondpoints displaced from the respective first and second sling free endssuch that an intermediate portion of the plicating line extends across acentral portion of the urethral sling intermediate first and second endportions of the urethral sling; surgically affixing the first sling endto a right descending pubic rami of a patient and affixing the secondsling end to a left descending pubic rami of the patient so that thecentral portion of the sling extends across the urethra; drawing theplicating line free ends together to induce tension in the first andsecond end portions and apply tension across the central portion of theurethral sling; and tying the plicating line free ends together; whereinthe step of drawing the plicating line free ends together furthercomprises shortening a dimension of the central portion of the urethralsling.